Importance Score: 75 / 100 🔴
FDA Issues Warning on Hair Loss Drug Side Effects
The Food and Drug Administration (FDA) has cautioned consumers about potential adverse reactions linked to topical finasteride, a common hair loss treatment available through various online platforms. Millions of Americans use these products to combat hair thinning and boost regrowth.
Concerns Regarding Topical Finasteride Products
While these hair loss solutions, often marketed as sprays or serums, require a prescription, they are readily accessible through telehealth companies like Hims, Hers, and Ro. Despite their popularity, the FDA has not approved these specific topical formulations.
Accessibility and Prescription Process
Obtaining a prescription for these hair growth products typically involves a brief online consultation with a doctor, making them easily obtainable for many individuals.
Limited Information on Side Effects
Although the products heavily promote their effectiveness, they often provide minimal information about potential side effects. FDA records indicate 32 complaints related to these products between 2019 and 2024.
Reported Adverse Effects
Consumers have reported experiencing a range of debilitating side effects, including:
- Erectile dysfunction
- Anxiety
- Suicidal thoughts
- Brain fog
- Depression
- Fatigue
- Insomnia
- Decreased libido
- Testicular pain
These issues emerged after using the topical hair loss treatments.
Persistence of Symptoms
Alarmingly, many individuals reported that these adverse effects persisted even after discontinuing the use of the products.
Impact on Quality of Life
Some complainants detailed how these symptoms led to depression, chronic pain, and a significant decline in their overall quality of life.
Unverified Reports and Additional Warnings
It’s crucial to note that these reports are unverified, meaning a direct causal link between the products and the reported side effects cannot be definitively established.
Risk to Pregnant Women
The FDA also warns that the medication poses a risk of causing abnormalities in a male fetus if exposed to pregnant women.
Lack of Awareness
Many consumers claimed they were not adequately informed about the potential adverse events associated with topical finasteride use.
Misinformation from Providers
Some patients reported being told by healthcare providers that the topical nature of the products eliminated the risk of adverse effects, unlike oral medications.
Other Potential Side Effects
The FDA lists additional side effects associated with finasteride lotions or serums, including:
- Irritation
- Erythema (skin rash)
- Dryness/Scaling
- Stinging
- Burning
Risk of Secondary Exposure
The agency also notes that these creams and serums can expose others to the medication through skin contact, as they are easily absorbed.
FDA-Approved Alternatives
Currently, two FDA-approved oral finasteride products are available in the US: Proscar and Propecia. However, no topical finasteride formulation has received FDA approval.
Case Study: The Dangers of Finasteride Pills
Mark Millich, a former US Army sergeant, sought an internet solution for his hair loss. He completed an online questionnaire with Hims.com and received anti-balding pills without directly consulting a doctor.
Unexpected Side Effects
Within six months, Millich experienced dizziness, fatigue, slurred speech, and emotional numbness. He also suffered muscle loss and changes in skin elasticity.
Worsening Condition After Discontinuation
After stopping the medication, Millich’s condition worsened, leading to a decreased libido and physical changes. He alleges that the company failed to adequately inform him about the drug’s potential side effects.
Finasteride: Mechanism of Action
Finasteride, the generic form of Propecia, is often prescribed for male pattern baldness to stimulate hair growth and increase hair count.
Impact on DHT
The drug works by inhibiting the production of 5α-reductase, an enzyme that converts testosterone into DHT (dihydrotestosterone). DHT causes hair follicles to shrink and eventually stop producing hair.
The Role of DHT
DHT is also essential for sexual function and genital health, and reducing its levels can lead to sexual side effects.
Post-Finasteride Syndrome (PFS)
In cases like Millich’s, side effects can persist even after discontinuing the drug, a condition known as Post-Finasteride Syndrome (PFS). This syndrome can include long-term sexual dysfunction, depression, and cognitive impairment.
Increased Usage of Finasteride
As of 2024, over 2.6 million Americans are using finasteride for hair loss, marking a significant increase in recent years, according to a report by Epic Research.
Prevalence of Side Effects
Studies suggest that a notable proportion of users experience at least one major side effect.
Expert Opinions
Dr. Justin Houman, a urologist, noted an increase in young men experiencing sexual side effects from finasteride, attributing it to the drug’s easy accessibility through online platforms. He advises against its use by young men.
Company Response
A Hims.com spokeswoman stated that customers undergo a comprehensive review by a licensed provider to determine medication eligibility. The company also claimed that treatments are part of plans designed and led by medical experts.
Commitment to Transparency
Hims.com stated that they are committed to transparency, providing customers with essential information, including potential side effects, to facilitate informed decisions and safe medication use.